Method of controlling transmission of defects

ABSTRACT

Apparatus useful in preventing or reducing risks of transmitting an infectious disease, primarily AIDS, or genetic disorder, comprises identification means such as a personal card bearing identity particulars of a first participant and security feature(s) and a storage medium such as a certificate or data based, bearing legible or retreivable test result data concerning the particular defect. A second participant consults the result before permitting intimate contact or accepting a donation of blood, body tissue or similar material.

This invention is concerned with methods of preventing or reducing therisks of transmission of defects from one participant to another, e.g.from one human being to another human being or to an organisation. Moreparticularly it is concerned with such methods of preventing, orsubstantially reducing the risk of transmission of a communicabledisease or disorder. By communicable disease or disorder we include, forexample infectious ailments be they viral, bacterial or the like andgenetically transmissible disorders.

The invention may find application amongst humans who are contemplatingintimate contact or contemplating donation of body fluids or materialfor reception or use by a second participant. The invention may also beuseful to persons or organisations responsible for such donations asblood banks, hospitals, transfusion centers, medical teams and the like.The invention could even be useful in the field of animal husbandry as ameans of controlling undesirable disease or disorder under humansupervised breeding conditions.

Use of the invention may be a systematic control method to help stop thespread of communicable disease or disorder in which medical treatment isnot required. As will become apparent, the invention has a principalapplication in stemming further spread of sexually communicable diseasesamongst humans, notably Acquired Immune Deficiency Syndrome (AIDS) forwhich there is currently no cure and to a lesser extent, the venerealdiseases such as syphilis, gonorrhea or herpes. The invention may alsofind application in preventing, or substantially reducing the risks oftransmission of a genetic disorder from one generation to another e.g.to an offspring of a participant. In this field of hereditary defectsthe invention may be useful in controlling such communicable defects as,for example, mongolism, cystic fibrosis, haemophilia, diabetes andsickle cell amaemia.

The following terms and expressions are used throughout the descriptionand claims to include the following:

"First Participant": an individual contemplating intimate contact withor donation to a second participant; or a first animal for breeding ordonation purposes.

"Defect": communicable disease or disorder being infectious or geneticwhich may adversely affect the health or function of an individual oranimal. The term is used to include any sexually communicable diseaseamongst living beings, especially AIDS.

"Second Participant": an individual contemplating intimate contact witha user, a second animal for breeding or donation-receiving purposes oran individual, group, team, organisation and the like which receives ormonitors donated body fluid or material, or contemplates such receipt.

As examples of body fluid or material that may be donated we includehuman or animal blood that can be used either immediately orsubsequently for transfusion, for conversion into blood products such asseparation into blood plasma, or concentration and separation in factorVIII, and e.g. bone marrow for immediate or subsequent transplantation.We also include organs for transplantation, for example, one kidney froman individual (first participant) to a related individual (secondparticipant) when both such individuals are live or posthumous donationof vital organs such as kidneys, heart, lungs in the event of anuntimely death of first participant. Individuals wishing to donate anysuch organs may carry a donor card expressing a wish or preference for adonation or, alternatively, the decision to donate may be made byrepresentatives of the donor, for example, the parents (as secondparticipants in a monitoring function) of an individual recently killed.Before a medical team may wish to use any donated organs they mayrequire up-to-date information in respect of potentially damagingdefects such as contamination by the AIDS virus or subject tohaemophilia genetic disorder and the like.

As a suitable body fluid which may be donated by individuals or animalswe also include semen which may be stored in a sperm bank and used forartificial insemination. It may be advantageous for the recipient(second participant) of such semen to have up to date information inrespect of any required defect by having access to a test result inrespect of that defect for such donated material.

The invention is useful in preventing transmission of disease ordisorder from a potential carrier, which may be anyone or any animalwithin a given population, to a potential recipient of that disease ordisorder. The invention may therefore be useful to people concerned withanimal husbandry but principally to individuals as first and secondparticipants contemplating intimate contact where there exists a risk ofacquiring an infectious disease. As will become apparent this can beprovided by independent test result for assessment by a secondparticipant.

In many countries there is considerable anxiety over the spread of thecommunicable disease known as AIDS. Three possible methods ofcontrolling the spread include find a cure, find a vaccine or separatethe AIDS infected carriers from intimate or other risky contact with therest of the population. The first two solutions are currently consideredto be unobtainable in the immediate future. The separation proposal hasbeen the only practicable step at the present time.

The importance of controlling further spread of AIDS into the non-AIDSinfected population is becoming more and more important in the UnitedKingdom and is already a problem in countries such as the United Stateswhere many persons are AIDS infected.

The majority of organised attempts to isolate carriers of the AIDS humanimmunodeficiency virus HIV from the contact with the remainingpopulation have been directed at isolating the sick from the healthy,i.e. those infected from those who are not. The AIDS virus has a longincubation period and for this reason any control measures are likely toaffect the sensitive issue of personal liberty. The present invention isbased on a surprisingly different approach to the problem in that it isconcerned with isolating the healthy from the sick rather than theconverse. Any attempts by individuals to isolate themselves frompotential or actual carriers of AIDS have been haphazard. It has beenobserved that individuals at risk of contacting AIDS have limited thenumber of intimate contacts made with others.

Use of the present invention permits a still further and significantreduction of risks and therefore may save lives and reduce anxiety andstress amongst individuals who use the apparatus and/or method accordingto the invention.

According to this invention there is provided a method of controllingtransmission of a defect from a first participants to a secondparticipants comprising:

(a) supplying the first participant with identification means,

(b) performing a test for presence or absence of the defect upon or inrelation to the first participant,

(c1) producing in legible or retrievable form a test result in a storagemedium identifying the first participant or (c2) storing the test resultin a database followed by (c3) retrieval of that result,

(d) informing the second participant of the test result,

(e) establishing an accept or reject decision by or on behalf of thesecond participant, and

(f) permitting contact between first and second participant or donationfrom first to second participant if step (e) results in a decision toaccept.

Optionally the first participant may repeat that test or have adifferent test for another communicable disease or disorder performed atany stage after (a). Furthermore, the first participant may decide toterminate the sequence before step (d) if the particular test isunfavorable, e.g. after a diagnosis of AIDS antibody positive.

In step (c1) of the method the result may be stored legibly on anindependently issued certificate and this proof of result may bepresented to or sent to the individual (first participant) immediatelyupon completion of the test. The individual will then be at liberty todisclose this to any second participant of his choosing. Alternatively,the test result may be stored on or in electronic, optical or magneticstorage medium such as a database and subsequently retrieved by thesecond participant with express or implicit permission from the firstparticipant. This may be achieved by the second participantinterrogating the appropriate storage medium to retrieve the result andpossibly have a permanent record of it by certificate, print out or thelike. This may be done in the presence of the first participant or byfurnishing consent to a data center operator who stores a plurality oftest results on a specific database. A second participant may be given asecret access code from the first participant to retrieve the testresult from the storage medium (e.g. database) without the intermediaryof an operator.

Such interrogation of a database may produce a result by audio and/orvisual means such as, for example, a printed record being obtained atthe request of the recipient.

It may be convenient for the identification means to comprise a personalidentity card similar to plastic credit cards in common use. Theidentity information may include a photograph, a name, a legible codeand/or a secret code. Examples of security features includepredetermined patterns and/or holograms. The storage medium may simplycomprise paper such as a certificate bearing a legible test resultgiving date, type and result of test, plus information identifying thefirst participant. Alternatively the storage medium may be electronic,optical or magnetic, in which case the test result would be retrievableand then could be made permanently legible if desired.

In one embodiment the identification means is a personal card bearing amagnetic strip having the test result stored on it. The result can beretrieved subsequently.

One convenient test for a first participant is carried out on a bloodsample, e.g. the test for AIDS antibodies. The present apparatus andmethod is especially useful in controlling the further spread ofsexually transmissible disease or disorder.

The present apparatus can be used in conjunction with means forretrieving a non-legible test result carried on the storage medium. Forexample an electronic decoder and display unit optionally with printingmeans.

In order that the invention may be illustrated and readily carried intoeffect, embodiments thereof will now be described by way of example onlywith reference to the accompanying drawings, in which:

FIG. 1 includes illustrations of a front and reverse sides of anidentification means preferably used with the present invention,

FIG. 2 is a diagram of a storage medium carrying legible test result,and

FIGS. 3 and 4 are flow charts of methods that may be carried out usingthe apparatus features.

FIGS. 1 and 2 relate to structures to be used immediately prior tocontemplated or to proposed intimate contact between a first participantand a second individual participant. It may equally apply with somemodifications where intimate contact is proposed between animals, underhuman-supervised breeding conditions or for establishing the suitabilityof donated body fluid or material for subsequent transfusion or otheruse. All participants may subscribe to a defect screening system inwhich a data center, controlled by an operator, stores test results on adatabase and permits retrieval of results under authorised terms.

The first participant is provided with a card similar to a creditcard 1. The card has a legible code 4, a secrete code 7 (invisible), aphotograph 2 of the holder, and a hologram (not shown). It should benoted that the name and signature of the user are unnecessary. The cardalso has a logo 3, an address 5 and telephone number 6 of a data centerwhich stores the test results.

The first participant has his blood tested at least once, preferablyperiodically, at a suitable location e.g. one approved by the abovenoted screening system operator. The data center would verify theauthenticity of the card and note the legible code. The result of thetest, the type of test, the date of the test and the code on the cardwould be sent to the operator if it is to be stored on a database forsubsequent retrieval. This information could even be applied to amagnetic electronic or optical recording strip on one side of the card(not shown).

Instead of storage the test result can be compiled as a certificate, seeFIG. 2, which shows a tangible certificate 8 having optional logo 3,photograph 2 of first participant, security feature 4, date of test 9,type of test 10 and result of test 11. This certificate can be retainedby the first participant.

At any time that the first participant may wish to establish absence ofa defect to a second participant he may interrogate this database in thepresence of that second participant or otherwise expressly consent tointerrogation in his absence. The secrete code may be used to give rightof access to this database. An alternative way of presenting this dataafter retrieval would be for a data center operator to produce ondemand, a certificate explaining the test results of the firstparticipant. At any time desired the first participant may show thiscertificate of independent test to a second participant to establishabsence of defect. At that time a more informed decision to permitintimate contact or accept donation can be made thus helping control ofthe particular disease of disorder tested.

It should be the responsibility of the second participant to interprettest results to determine whether intimate contact or receipt/use ofdonation can be permitted.

Plastic cards are only one of many possible identification means toestablish a link between a first participant, the test result, thesecond participant and the storage means, e.g. database.

Operators may wish to communicate anonymous data across regions andcountries in order to improve the method and freedom of firstparticipants.

Many feasible ways exist for presenting test result data in such a wayas to enhance the ease of use while preventing fraud. For example, bytelephone, by videotex, by certificate and the like.

Participants using the apparatus and method may therefore makesubstantial contributions to controlling the spread of communicabledisease or disorder and consequently enhancing the health and well beingof the human or animal population.

For a general application of the method which illustrates the use of theapparatus the reader is referred to FIG. 3 whilst for a more specificexample, based on the FIGS. 1 and 2 apparatus the reader is referred toFIG. 4. The flowcharts themselves are self-explanatory with an indexgiven relating to each particular step in the method as defined above.

The invention can be seen to involve testing of living beings or liveorgans or useful body fluid/material for certain physical parameters anda secure system of passing information to individuals or groups etc. atthe choice of the first participant.

Testing for presence or absence of defects is meant to include all meansand methods for performing such tests, for example by testing samples ofblood, urine, skin, flesh, organs, semen, breath, hair or nails. In somecases certain tests may not require removal of a sample but these may beperformed in situ.

An important application of the present invention is in the screening ofblood donations by blood banks acting as second participants. Presentarrangements for screening are not altogether satisfactory and incertain countries blood is donated for financial reward. In such asituation the donors (first participants) can be infected by acommunicable disease such as AIDS or hepatitis virus but the blood bankunknowingly accepts their donation and payment is made. It is only afterpayment that such blood is tested and sometimes destroyed because of thepresence of a potentially harmful defect.

By using the present apparatus or method these unnecessary expenses andrisks may be circumvented, particularly if the test results are securelystored on a database and access thereto is carefully controlled.

The data center, if used, may pair or twin participants by e.g.supplying both participants' identity card numbers to the operator. Whensuch links are present in the data center all such participants may benotified who could have become infected by e.g. AIDS virus throughcontact with other participants. When the participant interrogates theirown data, they may receive a warning to have medical attention and/orexercise caution in future intimate contacts or donations.

I claim:
 1. A method of enabling a reduction in the transmission of adefect in the nature of a communicable disease or a disorder from afirst participant to a second participant, the defect beingtransmittable by a contemplated transfer of body fluid from the firstparticipant to the second participant, comprising the steps of:(a)supplying a first person having control over the first participant withan identification means, (b) testing the first participant for thedefect and deriving a first indication of the test result, (c) storingthe first indication resulting from the test of step (b) with a secondindication of the identity of the first participant, the secondindication being stored on the identification means supplied in step(a), (d) reading the stored first indication for the test on the firstparticipant immediately prior to a contemplated transfer of the bodyfluid from the first participant to the second participant, (e)supplying a second person having control over the second participantwith the identification means supplied in step (a) and with the storedfirst indication read during step (d) immediately prior to thecontemplated transfer of the body fluid from the first participant tothe second participant, to enable the second person to make a decisionas to whether the second participant is to engage in an activity withthe first participant which will result in a transfer of the body fluidfrom the first participant to the second participant.
 2. The method ofclaim 1 further including storing the first and second indications on aportable identification medium for the results of the test for the firstparticipant and the identity of the first participant, said portableidentification medium having said identification means; supplying saidportable identification medium with the stored first and secondindications to the first person, said portable medium being carried bythe first person, the first person supplying the portable medium withthe first and second indications thereon to the second person in step(e), step (d) being performed with the first and second indications onthe medium.
 3. The method of claim 2 wherein the portable identificationmedium is a personal card including a machine readable storage mediumhaving the test results of step (b) stored therein during step (c), step(d) being performed by reading the first and second indications storedduring step (c) with a machine reader.
 4. The method of claim 1 furtherincluding transferring the body fluid from the first participant to thesecond participant as a result of the decision made by the second personbeing that the first participant is free of the defect, as indicated bythe test of step (b) on the first participant.
 5. A method of enabling areduction in the transmission of a defect in the nature of acommunicable disease or a disorder from a first participant to a secondparticipant, the defect being transmittable by a contemplated transferof body fluid from the first participant to the second participant,comprising the steps of:(a) supplying a first person having control overthe first participant with an identification means, (b) testing thefirst participant for the defect and deriving a first indication of thetest result, (c) storing the first indication resulting from the test ofstep (b) in a data base at a data center and a second indication of theidentity of the first participant on the identification means suppliedin step (a), (d) reading the stored first indication for the test on thefirst participant from the data base at the data center immediatelyprior to a contemplated transfer of the body fluid from the firstparticipant to the second participant, (e) supplying a second personhaving control over the second participant with the identification meanssupplied in step (a) and with the stored first indication read duringstep (d) immediately prior to the contemplated transfer of the bodyfluid from the first participant to the second participant, to enablethe second person to make a decision as to whether the secondparticipant is to engage in an activity with the first participant whichwill result in a transfer of the body fluid from the first participantto the second participant. (f) communicating the data read at the datacenter to the second person via an electromagnetic communication link.6. The method of claim 5 wherein plural tests are performed from time totime for the defect on the first participant, the results of the mostrecent test being stored as the first indication in the data base at thedata center.
 7. The method of claim 6 further including the steps ofproviding the first person with a portable card having thereon a secretemachine readable code with coded indicia providing a right of access tothe data base, step (d) being performed in response to the coded indiciaon the portable card being read by a machine to derive a signal, andtransmitting the thus derived signal to the data center via anelectromagnetic link, and accessing the data base at the data center inresponse to the thus derived signal as transmitted to the data center.8. The method of claim 6 further including transferring the body fluidfrom the first participant to the second participant as a result of thedecision made by the second person being that the first participant isfree of the defect, as indicated by the test of step (b) on the firstparticipant.
 9. The method of claim 6 wherein plural tests are performedfrom time to time for the defect on the first participant, the resultsof the most recent test being stored as the first indication in the database at the data center.